BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    GC12 Flex

    Reg #: 9680510 · FEI: 3003708031 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CARDIOCOMM SOLUTIONS, INC.
    Registration Number
    9680510
    FEI Number
    3003708031
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18 Wynford Drive, Suite 305
    City
    North York Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K111320

    Owner / Operator

    Firm Name
    CardioComm Solutions, Inc.
    Operator Number
    9009563
    Address
    18 Wynford Drive, Suite 305
    City
    Toronto
    State
    Ontario
    Postal Code
    M3C2S2
    Country
    CA

    US Agent

    Business Name
    AJW Technology Consultants, Inc.
    Contact Name
    Jon Ward
    Address
    11705 Boyette Road, #503
    City
    Riverview
    State
    FL
    ZIP
    33569
    Country
    US
    Email
    [email protected]
    Phone
    813 6452855 ext. 104

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH
    Electrocardiograph DPS

    Proprietary Names

    GC12 Flex GlobalCardio 12 Flex GlobalCardio GC12 GlobalCardio Flex GlobalCardio 12

    Establishment Types

    Manufacture Medical Device